Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Extension of the Comment Period

Published date28 May 2020
Citation85 FR 32040
Record Number2020-11455
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 85 Issue 103 (Thursday, May 28, 2020)
[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
                [Notices]
                [Pages 32040-32041]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-11455]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2018-D-1398]
                Mitigation Strategies to Protect Food Against Intentional
                Adulteration; Draft Guidance for Industry; Extension of the Comment
                Period
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice of availability; extension of comment period
                -----------------------------------------------------------------------
                SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
                extending the comment period for the notice of availability that
                appeared in the Federal Register of February 14, 2020, entitled
                ``Mitigation Strategies to Protect Food Against Intentional
                Adulteration; Draft Guidance for Industry.'' This supplemental draft
                guidance document, when finalized, will help food facilities that
                manufacture, process, pack, or hold food, and that are required to
                register under the Federal Food, Drug, and Cosmetic Act comply with the
                requirements of our regulation entitled ``Mitigation Strategies to
                Protect Food Against Intentional Adulteration.'' FDA is taking this
                action in response to a request for an extension to allow interested
                persons additional time to submit comments.
                DATES: FDA is extending the comment period on the notice of
                availability published February 14, 2020 (85 FR 8599). Submit either
                electronic or written comments on the supplemental draft guidance by
                August 14, 2020.
                ADDRESSES: You may submit comments on any guidance at any time as
                follows:
                Electronic Submissions
                 Submit electronic comments in the following way:
                 Federal eRulemaking Portal: https://www.regulations.gov.
                Follow the instructions for submitting comments. Comments submitted
                electronically, including attachments, to https://www.regulations.gov
                will be posted to the docket unchanged. Because your comment will be
                made public, you are solely responsible for ensuring that your comment
                does not include any confidential information that you or a third party
                may not wish to be posted, such as medical information, your or anyone
                else's Social Security number, or confidential business information,
                such as a manufacturing process. Please note that if you include your
                name, contact information, or other information that identifies you in
                the body of your comments, that information will be posted on https://www.regulations.gov.
                 If you want to submit a comment with confidential
                information that you do not wish to be made available to the public,
                submit the comment as a written/paper submission and in the manner
                detailed (see ``Written/Paper Submissions'' and ``Instructions'').
                Written/Paper Submissions
                 Submit written/paper submissions as follows:
                 Mail/Hand Delivery/Courier (for written/paper
                submissions): Dockets Management Staff (HFA-305), Food and Drug
                Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                 For written/paper comments submitted to the Dockets
                Management Staff, FDA will post your comment, as well as any
                attachments, except for information submitted, marked and identified,
                as confidential, if submitted as detailed in ``Instructions.''
                 Instructions: All submissions received must include the Docket No.
                FDA-2018-D-1398 for ``Mitigation Strategies to Protect Food Against
                Intentional Adulteration: Supplemental Draft Guidance for Industry.''
                Received comments will be placed in the docket and, except for those
                submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
                and 4 p.m., Monday through Friday.
                 Confidential Submissions--To submit a comment with
                confidential information that you do not wish to be made publicly
                available, submit your comments only as a written/paper submission. You
                should submit two copies total. One copy will include the information
                you claim to be confidential with a heading or cover note that states
                ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
                review this copy, including the claimed confidential information, in
                its consideration of comments. The second copy, which will have the
                claimed confidential information redacted/blacked out, will be
                available for public viewing and posted on https://www.regulations.gov.
                Submit both copies to the Dockets Management Staff. If you do not wish
                your name and contact information to be made publicly available, you
                can provide this information on the cover sheet and not in the body of
                your comments and you must identify this information as
                ``confidential.'' Any information marked as ``confidential'' will not
                be disclosed except in accordance with 21 CFR 10.20 and other
                applicable disclosure law. For more information about FDA's posting of
                comments to public dockets, see 80 FR 56469, September 18, 2015, or
                access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
                 Docket: For access to the docket to read background documents or
                the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
                the heading of this document, into the ``Search'' box and follow the
                prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
                Rm. 1061, Rockville, MD 20852, 240-402-7500.
                 You may submit comments on any guidance at any time (see 21 CFR
                10.115(g)(5)).
                 Submit written requests for single copies of the guidance to the
                Center for Food Safety and Applied Nutrition, Food and Drug
                Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
                addressed adhesive labels to assist that office in processing your
                requests. See the SUPPLEMENTARY
                [[Page 32041]]
                INFORMATION section for electronic access to the draft guidance
                document.
                FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety
                and Applied Nutrition (HFS-005), Food and Drug Administration, 5001
                Campus Dr., College Park, MD 20740, 240-402-3712,
                [email protected].
                SUPPLEMENTARY INFORMATION: In the Federal Register of February 14, 2020
                (85 FR 8599), we published a notice announcing the availability of a
                supplemental draft guidance for industry entitled ``Mitigation
                Strategies to Protect Food Against Intentional Adulteration: Draft
                Guidance for Industry.'' This multichapter supplemental draft guidance
                for industry is intended to help food facilities required to comply,
                develop, and implement some of the components of a food defense plan,
                and meet other requirements under 21 CFR part 121.
                 The Agency has received a request for an extension of the comment
                period for 120 days. The request conveyed concern that the current
                comment period does not allow sufficient time to develop a
                comprehensive response.
                 FDA has considered the request and is extending the comment period
                for the notice of availability for 60 days, until August 14, 2020. The
                Agency believes that a 60-day extension allows adequate time for
                interested persons to submit comments.
                 Dated: May 21, 2020.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2020-11455 Filed 5-27-20; 8:45 am]
                BILLING CODE 4164-01-P
                

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